REFLEX HYBRID 48674012Recalls & reported problems
Stryker Corporation · FIXED, SELF-TAPPING SCREW · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540392947), received between May 17, 2016 and May 17, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Failure To Adhere Or Bond1
- Mechanical Problem1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2016Failure To Adhere Or Bond; Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated
IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT THE SURGERY. ON (B)(6) 2016, THE SURGEON CONFIRMED X-RAY AND FOUND THAT THE SCREW INSERTED IN THE BONE IS LOOSENING. THE SURGEON IS MONITORING FOR THE PATIENT NOW.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 5661430 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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